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Mammalian cell culture platform
Microbial fermentation platform
Gene therapy(AAV)
GMP Manufacture
Formulation, F&F
Innovative Technology Platform
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BiBo R&D Centers (Boston, Shanghai)
BiBo P01 (Shanghai Zhangjiang)
BiBo P02 (Shanghai Lingang)
BiBo P03 (Shanghai Lingang)
Customized production lines
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Mammalian cell culture platform
Microbial fermentation platform
Gene therapy(AAV)
Sequence Confirmation
Cell line/Strain development & Plasmid generation
Analytical Assays Development
Process development
Cell bank preparation
Tech. Transfer/ GMP campaign preparation
Pilot/Clinical phase manufacture(GMP)
Engineering service
Commercial launches
PAI support
NDA/BLA
PPQ (PV)
Process characterization study
IND Filings
Sequence Confirmation
Cell line/Strain development & Plasmid generation
EPIC-2BOX Mammalian cell(EPIC-CHO
TM
)
Mammalian cell(EPIC-CHO™)
Microbial
Vector design and construction
Single-clone screening
Cell bank preparation and characterization study
Genetic stability study
pDNA
RCB (Research Cell Bank)
Analytical Assays Development
Analytical Assays Development
Identity testing
Determination assays
purity testing
Safety testing assays
Activity testing assays
Impurity residue testing assays
Analytical Assays Transfer
Analytical Assays confirmation and Validation
Process development
Media screening/optimization/composition design
Upstream process development and optimization
Downstream process development and optimization
Formulation development (clinical stage/ commercial stage)
Formulation development
Formulation process development
Lyophilization process development
Medical device Combination Product Development
AAV platform
Adherent
Suspension
XcelaRax
®
Cell bank preparation (MCB/WCB)
Microbial/Mammalian cell banking
MCB/WCB preparation and characterization
Genetic stability study of the cell bank
Storage and temperature monitoring under GMP conditions
Tech Transfer/ GMP manufacturing
Tech Transfer/Process development
Analytical assays transfer and validation
Raw material procurement and release
Pilot/Clinical phase manufacture (GMP)
DS
Microbial: 20L/50L/200L/500L/2000L
Mammalian: 200L/500L/2000L
AAV: Cell factory/20L/50L/200L/500L
DP
Liquid vial
Lyophilization
Pre-filled syringe
Others
IND Filings
China
US
European Union (EU)
Other: Australia, etc.
Process characterization study (PC)
Building and validation of the scale-down model
FMEA&DoE
Definition of CPP&KPP
Establish control strategy
Resin lifecycle study
PPQ(PV)
PV batch production (DS/DP)
GMP release and stability study
NDA/BLA
PAI support
China: NMPA
US: FDA
Europe: EMA
Other: ANVISA/TGA, etc.
Commercial launches
DS
Microbial: 200L/500L/2000L/8000L/30000L
Mammalian cell: 200L/500L/2000L/3000L/8000L/30000L
AAV: Cell factory/200L/500L/2000L
DP
Liquid vial
Pre-filled syringe
Lyophilization
Cartridge
other
DS/DP GMP Release and stability study
Engineering service
GMP site design
PanFlex
®
-Engineering
GMP factory construction project management
Sequence Confirmation
Cell line/Strain development & Plasmid generation
Analytical Assays Development
Process development
Cell bank preparation (MCB/WCB)
Tech Transfer/ GMP manufacturing
Pilot/Clinical phase manufacture (GMP)
IND Filings
Process characterization study (PC)
PPQ(PV)
NDA/BLA
PAI support
Commercial launches
Engineering service
If you have any questions, please contact us and fill-up the form. We will get back to you as soon as possible!
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